Cleared Traditional

KALLESTAD SM/RNP TEST REAGENT

K862313 · Kallestad Laboratories, Inc. · Immunology
Aug 1986
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K862313 is an FDA 510(k) clearance for the KALLESTAD SM/RNP TEST REAGENT, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on August 6, 1986, 49 days after receiving the submission on June 18, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K862313 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1986
Decision Date August 06, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LKJ — Antinuclear Antibody, Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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